A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination With Dexamethasone in T-ALL/T-LBL Patients

Status: Completed

Location: See all (22) locations...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1/Phase 2

SUMMARY

The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with dexamethasone in participants with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma (T-ALL/T-LBL).

Eligibility

Participation Requirements

Sex: All

Minimum Age: 2

Healthy Volunteers: f

View:

• Have acute T-cell lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).

• T-ALL or T-LBL participants with relapsed/refractory disease.

• Have had at least 60 days between prior hematopoietic stem cell transplantation (SCT) and first dose of study drug.

• Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale for adults.

• Lansky score \>50% for participants \<16 years old.

• Have adequate organ function.

• Are at least:

‣ adult Phase 1 Part A and Phase 2: ≥16 years old at the time of screening

⁃ pediatric Phase 1 Part B: 2 to \<16 years old

• Men and women with reproductive potential: Must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug(s) or country requirements, whichever is longer.

• Females with childbearing potential: Have had a negative serum pregnancy test ≤7 days before the first dose of study drug and also must not be breastfeeding.

• Are able to swallow capsules and tablets.

Locations

United States

California

City of Hope National Medical Center

Duarte

Massachusetts

Dana Farber Cancer Institute

Boston

Michigan

Karmanos Cancer Institute

Detroit

New York

Montefiore Medical Center

Bronx

Memorial Sloan Kettering Cancer Center

New York

Pennsylvania

University of Pennsylvania Hospital

Philadelphia

Texas

University of Texas MD Anderson

Houston

Other Locations

France

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Lille

Nantes

Paris

Pierre Benite

Toulouse

Germany

Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt

Universitätsklinikum Heidelberg

Heidelberg

Ulm

Israel

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Haifa

Jerusalem

Ramat Gan

Tel Aviv

Italy

Milano

Napoli

Torino

Time Frame

Start Date: 2015-10-01

Completion Date: 2018-01-15

Participants

Target number of participants: 36

Treatments

Experimental: LY3039478 + Dexamethasone (Adult)

Part A: 50 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.~75 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.~100 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.~125 mg LY3039478 administered orally three times per week (TIW) and 24 mg dexamethasone administered orally on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.

Experimental: LY3039478 + Dexamethasone (Pediatric)

Part B: LY3039478 administered orally TIW at escalating doses and dexamethasone administered orally twice a day (BID) on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.~There were no participants enrolled to Part B of the study.

Experimental: Phase 2: LY3039478 + Dexamethasone

LY3039478 administered orally TIW and dexamethasone administered orally BID on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.~There were no participants enrolled to Phase 2 of the study.

Placebo_comparator: Phase 2: Placebo + Dexamethasone

Placebo administered orally TIW and dexamethasone administered orally BID on days 1-5 every other week during 28 day cycles. Participants receiving benefit may continue until disease progression.~There were no participants enrolled to Phase 2 of the study.

Authors

Jae Park, Ibrahim Aldoss, Carolyn Mulroney, Gautam Borthakur, Alexander Perl, Jay Yang, Nicola Gökbuget, Christoph Lutz, Daniel DeAngelo, Murali Janakiram

Related Therapeutic Areas

Acute Lymphoblastic Leukemia (ALL)

Leukemia

A Phase 1b/Randomized Phase 2 Study to Evaluate LY3039478 in Combination With Dexamethasone in T-ALL/T-LBL Patients

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